Observational Study in Patients With Previously Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab (MESO-IMMUNE)
MESO-IMMUNE
Multicenter Observational Retrospective French Study in Patients With Previously Untreated, Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab Via an Early Access Program
1 other identifier
observational
204
1 country
63
Brief Summary
Meso-Immune is a retrospective study to assess the efficacy and safety of the combination of Nivolumab and Ipilimumab used in first-line treatment of adult patients with unresectable Malignant Pleural Mesothelioma (MPM). This combination of treatments has been approved in Europe since June 2021 based on the results of the CheckMate 743 study. In France, the combination is not yet reimbursed for this population of patients. However, since April 01, 2021, newly diagnosed unresectable MPM patients may be treated with this combination via an early access program. Meso-Immune study targets these patients included in the early access program with the objective to provide additional results to the CheckMate 743 study and confirm the benefit of using this combination in first-line of treatment in this category of patients. Total study duration will cover 48 months with an inclusion period of 12 months and a follow-up until 3 years. Patients will be recruited retrospectively starting April 01, 2021 until April 01, 2022. Meso-Immune study will be proposed to all the GFPC centers that have already included patients in the early access program and other centers wishing to participate, in order to analyze a minimum of 150 patients. The total number of sites is evaluated at around 120. The principal investigator in each center will identify the patients eligible for the Meso-Immune study and will inform them on the study according to the local regulations. Patient follow-up will be pursued regularly, in in-patient and out-patient clinics, according to the usual practices of the physicians in each participating center. Reevaluation workups will be pursued according to the practices of each center. The information related to Patient characteristics, MPM characteristics, Treatment characteristics, Disease progression, Rebiopsy, Post treatments, Adverse events, Date and cause of death, Date of last news will be recorded in electronic case-report forms (eCRF). Qualitative variables will be presented descriptively in the principal analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Typical duration for all trials
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedStudy Start
First participant enrolled
May 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2025
CompletedOctober 6, 2025
August 1, 2025
3.3 years
January 17, 2022
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival assessed locally
Progression free survival as assessed by the investigator, defined as the time from first dose of combination Nivolumab-Ipilimumab to first documentation of disease progression or to death from any cause, whichever came first
time from first dose of combination Nivolumab-Ipilimumab to first documentation of disease progression or to death from any cause evaluated through the total duration of the study (up to 48 months)
Secondary Outcomes (16)
Potential professional exposure(s)
At Baseline
Eastern Cooperative Oncology Group performance status (PS)
At Baseline
Body weight
At Baseline
Body mass index (BMI)
At Baseline
Smoking status
At Baseline
- +11 more secondary outcomes
Study Arms (1)
Patient presenting MPS treated with nivolumab and ipilimumab
Adult patients with previously untreated and unresectable Malignant Pleural Mesothelioma (MPM) treated with combination of Nivolumab and Ipilimumab in the setting of the early access program not opposed to the collection of their data
Interventions
Observational study without intervention except retrospective and prospective data collection : Patient characteristics, MPM characteristics, Treatment characteristics, Disease progression, Rebiopsy, Post treatments, Adverse events, Date and cause of death, Date of last news ; recorded in electronic case-report forms (eCRF).
Eligibility Criteria
Adult patients with previously untreated and unresectable Malignant Pleural Mesothelioma treated with combination Nivolumab and Ipilimumab in the setting of the early access program not opposed to the collection of his/her data
You may qualify if:
- Patient with previously untreated and unresectable Malignant Pleural Mesothelioma treated with combination Nivolumab and Ipilimumab in the setting of the early access program
- Patient enrolled in the French National Health Insurance program or with a third-party payer
- Patient not opposed to the collection of his/her data (an information sheet will be to all living patients; for those who died, documented opposition to data collection in his/her medical file is not required)
You may not qualify if:
- Patient under curatorship or guardianship
- Patient's explicit refusal to collect his / her data
- Patients not managed at the investigating center and not followed by a center investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Groupe Francais De Pneumo-Cancerologielead
- Bristol-Myers Squibbcollaborator
Study Sites (63)
CHU du Pays d'Aix
Aix-en-Provence, 13616, France
CH Albi
Albi, 81013, France
CHU Angers
Angers, 49033, France
CH Argenteuil
Argenteuil, 95010, France
CH Avignon
Avignon, 84000, France
CH Bastia
Bastia, 20200, France
CH Bayonne
Bayonne, 64100, France
CHU Besançon
Besançon, 25000, France
Clinique Ambroise Paré
Beuvry, 63660, France
CH Bligny
Bligny, 91640, France
Clinique Bordeaux
Bordeaux, 33000, France
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100, France
CHU Morvan
Brest, 29200, France
Clinique Pasteur
Brest, 29200, France
Hôpital Louis Pradel
Bron, 69500, France
CHU Caen
Caen, 14033, France
CH Cannes
Cannes, 06400, France
CH du Cotentin
Cherbourg, 50102, France
CHU Hôpital Montpied
Clermont-Ferrand, 63000, France
Unicancer
Clermont-Ferrand, 63000, France
Hôpital Louis Pasteur
Colmar, 68000, France
CH Dijon Bourgogne
Dijon, 21000, France
CH Eure-Seine
Évreux, 27015, France
Clinique Gentilly
Gentilly, 94250, France
CHD les Oudaries
La Roche-sur-Yon, 85000, France
GH Le Havre
Le Havre, 76083, France
CH du Mans
Le Mans, 72000, France
CH Libourne
Libourne, 33500, France
CHU Lille
Lille, 59000, France
CH de Longjumeau
Longjumeau, 91160, France
Hôpital du Scorff
Lorient, 56100, France
Centre Léon Bérard
Lyon, 69373, France
IPC
Marseille, 13009, France
Hôpital Nord
Marseille, 13915, France
CAC Mougins
Mougins, 06250, France
CH Nevers
Nevers, 58000, France
Clinique Saint Georges
Nice, 06000, France
Centre Antoine Lacassagne
Nice, 06149, France
Institut Curie
Paris, 75005, France
Hôpital Cochin
Paris, 75014, France
Hôpital Bichat
Paris, 75018, France
Hôpital La Pitié-Salpêtrière
Paris, 75651, France
GH Paris Site St Joseph
Paris, 75674, France
Hôpital Haut-Lévèque - Groupe Hospitalier SUD
Pessac, 33604, France
CHU La Mileterie
Poitiers, 86021, France
CH Annecy Genevois
Pringy, 74374, France
CH Cornouaille
Quimper, 02900, France
CHU Ponchailloux
Rennes, 35000, France
Clinique Saint Grégoire
Rennes, 35000, France
Hôpital Charles Nicolle
Rouen, 76031, France
Hôpital privé de la Loire
Saint-Etienne, 42100, France
Insititut de Cancerologie de l'Ouest
Saint-Herblain, 44805, France
HIA Begin
Saint-Mandé, 94160, France
Clinique de l'Estuaire
Saint-Nazaire, 44600, France
CH St Quentin
Saint-Quentin, 02321, France
CH de Saint Malo
St-Malo, 35400, France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 76091, France
CHITS Toulon Sainte Musse
Toulon, 83056, France
HIA St Anne
Toulon, 83800, France
Hôpital Larrey
Toulouse, 31059, France
CHRU Bretonneau
Tours, 37044, France
CH Villefranche
Villefranche-sur-Saône, 69400, France
CH Villeurbanne
Villeurbanne, 69100, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christos CHOUAID
Groupe Français de Pneumo-Cancérologie (GFPC)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2022
First Posted
April 4, 2022
Study Start
May 3, 2022
Primary Completion
August 27, 2025
Study Completion
August 27, 2025
Last Updated
October 6, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share